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In This Issue:
ACT UP leads major drug protest in DC
US softens stance on AIDS drugs for poor countries
102 new HIV drugs in development
Twice-daily Viracept dosing approved by FDA
Grants won't be available for PWAs with housing vouchers
AIDS orphans will surpass 11 million this year
Syringe vending machines popular among young drug users
Activists launch attack on Mbeki
Female condoms may not be suitable for anal sex
FIGHT seeks PWAs for review board
In conjunction with worldwide protests aimed at the World Trade Organization's meeting this week in Seattle, WA, AIDS activists from ACT UP Philadelphia marched through the streets of Washington, D.C. yesterday to protest the Clinton administration's foreign trade policy that restricts compulsory licensing and parallel importing of AIDS drugs for developing countries.
At the meeting, President Clinton and U.S Trade Representative Charlene Barshefsky are expected to oppose exempting "essential medications" from patent protections.
Amidst chants of "pills cost pennies; greed costs lives," and "medication for every nation," protesters marched four blocks through the city ending in front of the White House. The march passed Bristol-Myers Squibb's District offices where protesters paused for several minutes to denounce the drug manufacturer's opposition to Thailand's efforts to develop a generic version of the company's AIDS drug ddI.
In accordance with WTO intellectual property agreements, Thailand is allowed to produce generic versions of the drug. However, the U.S. government, at the behest of Bristol-Myers, has threatened the country with trade sanctions if it continues to manufacture the less costly version of the medication.
Protesters hoisted the "Golden Funeral Urn" they awarded to the president symbolizing the millions of deaths they attributed to a trade policy they characterized as "corporate welfare for drug companies."
Ten activists were arrested in front of the White House after attempting to chain themselves to the fence. The protest ended with a choir singing "Amazing Grace."
The rally marked the release of the international HealthGap Coalition's "white paper" that documented several instances in which the Clinton administration placed "drug company concerns ahead of public health" in international trade agreements and WTO negotiations.
In a statement released Monday, ACT UP Philadelphia's Paul Davis said, "International human rights laws indicate that access to HIV and AIDS treatments is a human right. This administration's policies ignore human rights and prioritize profits over lives." He added, "On World AIDS Day at the end of the millennium, President Clinton has the blood of millions on his hands."
Dr. Larry Egbert of Doctors Without Borders spoke to the demonstrators about Thailand's current struggle with Bristol-Myers over ddI. Noting that the Nobel Peace Prize-winning organization is angry at the government's backing of Bristol-Myers' opposition, Egbert said that Doctors Without Borders is embarking on a campaign to heighten awareness of the situation. "We are letting people know that the U.S. is telling Thailand that they can't do this," he said.
Calling the U.S. pressure "shocking," ACT UP's Chris Kimmenez said that the rally was part of an extensive campaign to address the issue. "Everyone should have access to medications to allow them to live," he said. Pharmaceutical companies, including Bristol-Myers, contend that compulsory licensing would reduce the amount of money necessary to research and develop new, enhanced medications.
However, activists point to the enormous sums of money pharmaceutical companies spend on marketing their products. According to the company's annual report, Bristol-Myers spent more than $67 billion on marketing in 1998, compared to $16 billion on research and development. Lead protester and ACT UP member Asia Russell decried Clinton's "shameful" policy that protects the "power of the pharmaceutical industry ... before the lives of poor and suffering people with HIV."
Accusing the government of inflicting "genocidal" policies, Russell said, "Charlene Barshefsky thinks that's okay. Bill Clinton thinks that's okay. We know it's wrong." Speaking to the crowd gathered in front of the White House, Hassan Gibbs, an ACT UP member and long-time HIV survivor, said that while Americans with HIV have access to critical treatment, the poor nations of the world are clamoring for similar access. Noting that the U.S. government "continues to play puppet to the pharmaceutical companies," Gibbs expressed "outrage at the sheer corruption that millions of people with HIV in developing nations are having essential medication held back from them." He demanded that Clinton put an end to "deliberate roadblocks to life saving medications" and called for compulsory licensing that would allow developing countries to manufacture their own, less-costly version of HIV treatments.
(Kaiser Daily HIV/AIDS Report. This article is reprinted with permission from the Kaiser Daily HIV/AIDS Report. The Daily Report is published for The Henry J. Kaiser Family Foundation by National Journal Group Inc. Copyright 1999 by National Journal Group Inc., 1501 M St., N.W., Washington, DC 20005. All rights reserved. The Daily Report is available in its entirety free on the Kaiser Family Foundation's Web site, www.kff.org. You may also register for free e-mail delivery at www.kff.org/register.)
President Bill Clinton said on December 1st that the US may soften its defense of US drug company patents to help foreign countries that need the medicines to fight health crises, particularly AIDS.
In making the announcement on World AIDS Day, Clinton was seeking to defuse a bitter struggle between developing countries that want to use cheap generic drugs to fight diseases like AIDS and drug makers who argue that this infringes on patent rights and threatens investment in future drug development.
"Intellectual property protections are very important to a modern economy, but where HIV and AIDS epidemics are involved, and [similar] serious healthcare crises, the United States will henceforth implement its healthcare and trade policies in a manner that ensures people in the poorest countries won't have to go without medicine they so desperately need," Clinton said.
The White House said in a statement that the US Trade Representative and the Department of Health and Human Services would work together to develop a policy that balanced the intellectual property rights and public health interests.
"Through this approach, we will ensure the application of US trade law related to intellectual property remains sufficiently flexible to respond to legitimate public health crises," the statement said.
In another move, US Trade Representative Charlene Barshefsky announced that she is removing South Africa from a watch list for possible patent infringements after reaching a deal over access to drugs.
"The recent bilateral understanding developed with South Africa illustrates the complementary nature of sound public health and intellectual property policies," the U.S. embassy in Pretoria said in a statement.
The statement said under an agreement reached in September, both governments had reaffirmed the need to protect intellectual property rights, while addressing the health needs of South Africa, which is desperate to access cheap anti-AIDS drugs.
"Barshefsky took this action as a result of this understanding, as well as other steps South Africa has and is taking to improve further the protection of intellectual property," the embassy said.
The U.S. placed South Africa on the watch list after it sought to allow local manufacturers to make cheaper, generic copies of AIDS drugs or import medicines from a third party.
"The problem is to make sure that people who need it have access to care; and that includes drugs and medicines," Dr. Peter Piot, executive director of UNAIDS said in an interview with Reuters Health this week.
In some countries, AIDS qualifies under the compulsory licensing provision of the World Trade Organization's TRIP (Trade-Related Aspects of Intellectual Property Rights) agreement, Dr. Piot said. This agreement allows compulsory licensing of patents "in the case of national emergencies and in the case of abuse of patent rights."
However, Dr. Piot emphasized that many approaches need to be tried to increase the availability of drugs in countries where AIDS is a national emergency.
First of all, UNAIDS "firmly supports intellectual property protection and patent rights," he said. "Otherwise," he added, "we will never have new drugs."
In return for intellectual property protection, offering preferential pricing to poorer markets is the best solution, he said. "I think some companies are open to that and some are actually already doing it, like Glaxo Wellcome for AZT."
We then have to make sure these markets are shielded so that the products that are sold at a reduced price do not show up in the richer markets, which would undermine the whole process, he cautioned.
Another aspect of this issue that is not discussed much, Dr. Piot pointed out, is that in many countries there are very heavy taxes on imported medicines and condoms. These taxes may increase the price by 30% to 50%, or even double it. He believes that this is where governments need to step in.
Finally, "compulsory licensing can be used as a measure of last resort after the other [approaches] have been exhausted." Exercising this option will not be that simple, he explained. Countries need to have the capacity to produce these drugs through good manufacturing processes and so forth. The market also needs to be large enough so that it is profitable to produce antiretroviral drugs locally.
Dr. Piot believes that "we should be very realistic [about] what we can achieve." And for many countries, compulsory licensing is "not a solution right now."
ACT UP Philadelphia's Paul Davis and Julie Davids were less than impressed by the Clinton Administration announcements.
"These statements came one day after ACT UP sponsored demonstrations in Washington DC, San Francisco, New York City, and Oakland. ACT UP members and numerous other Health GAP member organization participated in forums, briefings, demonstrations, and press conferences in Seattle. These events all demanded that the US cease actions interfering with WTO-legal efforts to increase access to life saving medication," he said. "There may be hope that progress is being made."
"However, the statements were very short on specifics - and when specifics are hinted at or referred to, a serious cloud appears over the statements."
Davis and Davids said that they believed that the Clinton plan was an effort to "distract the public, the press, and the activists away from US opposition to proposals from many poor countries led by Venezuela and Kenya to remove life-saving medicines from patentability. These proposed resolutions would retain autonomy for poor countries, and save the lives of millions worldwide."
The also called the US statements "meaningless," noting that "there is no commitment to do anything other than to be 'flexible' and set up a 'process' by which these applications can be reviewed."
"Clinton and Barshefsky make repeated use of the words 'flexible,' to describe the new policy. Flexible, however, does not mean that poor countries will be allowed to manufacture or import affordable medicines as needed. Flexible means little, given the USTR's current willy-nilly application of 301 actions against nations attempting to save the lives of their residents with essential medicines."
The ACT UP analysis charged that the US plans to "continue to hold poor countries to standards that exceed the TRIPS agreement. The USTR statement says that USTR and HHS will meet to set up a process for HHS to comment on the validity of other nation's claims for making meds available. Poor countries will have to satisfy Barshefsky and Shalala that their health emergency and medical infrastructure merits the US government 'settling' for TRIPS. In doing so, it still insists that the US has the right to use TRIPS as a floor, not a ceiling -- allowing US to continue to pursue unilateral pressure rather than using the WTO dispute settlement process."
Davis and Davids said that the US continues to claim that compulsory licensing and parallel importing are only available in cases of "emergency," although international rules do not require that there be an emergency situation for the procedures to be utilized. (Reuters/ACT UP)
In addition to the 61 drugs that have been approved by the US Food and Drug Administration, 102 new therapies are currently in the pipeline, according to the results of a new survey conducted by the Pharmaceutical Research and Manufacturers of America (PhRMA).
Included in the 102 therapies are 11 preventive vaccines, as well as new antiretroviral compounds. Research focusing on drugs for refractory patients is also underway. Drugs for this patient subset include HIV fusion inhibitors, a new class of antiretrovirals that blocks the virus before it enters the cell, and a new protease inhibitor.
Other approaches include "adoptive immunotherapy," which uses autologous T-cell transfusion, and compounds that boost macrophage activity.
"In the 15 short years since the AIDS virus was identified, pharmaceutical companies have discovered and made available 61 medicines to treat this disease and its complications," Alan F. Holmer, PhRMA CEO commented.
"As we end the millennium, we have cut the US death rate from AIDS by more than 70% since 1995, thanks in large part to combination drug therapy. Other medicines have helped reduce the incidence of AIDS-related opportunistic infections by 70% in the US in the past 4 years."
Companies are also investigating ways in which existing antiretroviral regimens can be maximized. For example, the use of dual protease inhibitor combinations and potential gender differences in protease inhibitor response are being evaluated. (Reuters)
The US Food and Drug Administration has approved twice-daily dosing of the protease inhibitor nelfinavir (Viracept), according to statement by officials at Agouron Pharmaceuticals, Inc. on Monday.
The FDA decision was based on interim results of a phase III trial that is comparing the antiretroviral effects and safety profile of 1,250 mg b.i.d. nelfinavir with that obtained with the previously approved 750 mg t.i.d. nelfinavir dose.
Data from the phase III trial, which involves 500 patients, indicate that the two dosing schedules of nelfinavir produced comparable decreases in plasma HIV RNA load and increases in CD4+ T cell counts. Both nelfinavir doses were administered to patients in combination with stavudine and lamivudine.
Moderate or severe diarrhea was reported as a side effect by 14% to 18% of patients receiving either the b.i.d. or t.i.d. dose of nelfinavir in combination with two nucleoside analogues.
"We are gratified that the FDA has approved twice daily dosing for Viracept," Peter Johnson CEO of the La Jolla, California-based company commented. "This simpler and more convenient dosing schedule for Viracept, that preserves its safety, tolerability, and anti-HIV potency, will further enhance the utility of the most extensively prescribed HIV protease inhibitor in the United States."
The AIDS Activities Coordinating Office (AACO) has announced that it will no longer allow people living with HIV/AIDS who are receiving monthly rental assistance to also qualify for emergency financial support under the Direct Emergency Financial Assistance (DEFA) Program.
Recipients of monthly rental assistance (called "vouchers") are usually required to pay no more than 30 percent of their monthly income on their rent and utilities. Using funding provided under the federal Housing Opportunities for People with AIDS (HOPWA) program, AACO pays the remainder of the expenses. The program has allowed hundreds of local PWAs to obtain regular apartments that would otherwise be beyond their means.
Most of the recipients of AIDS housing vouchers are living on about $600 per month under the Social Security Supplemental Income (SSI) program.
DEFA is a separate program, supported by HOPWA and Ryan White funds, which provides up to $1500 per year in emergency financial assistance for PWAs to meet housing, medical and other crises. Federal officials recently issued a regulation prohibiting the use of most of the Ryan White funds for housing costs, citing the availability of HOPWA funding for these purposes. The vast majority of emergency grant requests relate to housing and utility payments.
According to the Philadelphia Gay News, AACO co-director Joseph Cronauer announced the new policy at a recent meeting of AIDS service organizations, saying that AACO will no longer "juxtapose" the voucher and emergency assistance funding streams. Many PWAs have complained that the emergency grant funds are being too rapidly depleted by people who are already receiving monthly rental assistance, while homeless and other desperately-needy PWAs, who do not have regular housing vouchers, are kept out.
The new policy was promptly condemned by Richard Gliniak, a member of the Philadelphia HIV Commission Housing Committee. He told PGN that "eligibility should be based on need, not how many programs you access. If they want to set income limits for recipients, that's one thing. But don't say, we'll get you this grant, so you can't get that grant. If the need is still there."
Luciano Orsini, a Housing Committee member who operates the AIDS rental assistance for the Tenants Rental Assistance Program, defended AACO's decision, saying that he hoped that it would result in "more people [being] helped, including those most in need."
"If you didn't have people abusing the systems in place, you could truly be serving the neediest of the needy," Orsini told PGN. "Right now, I'm not sure that's happening.
By the end of this year, 11.2 million children worldwide will be orphaned by the AIDS epidemic, according to a new report released by officials at UNAIDS and UNICEF at a special United Nations symposium held in New York City to commemorate World AIDS Day. Ninety-five percent of the estimated 11.2 AIDS orphans are in sub-Saharan Africa.
"The figures are staggering," Dr. Peter Piot, executive director of UNAIDS, commented in a press release issued by his organization. "By the end of the year 2000, we estimate that the cumulative number of AIDS orphans will rise to 13 million."
In the report, entitled "Children Orphaned by AIDS: Front-line Response from Eastern and Southern Africa," orphans were defined as children under the age of 15 who have lost their mother to AIDS.
"The scale of the orphan crisis is almost unimaginable," Carol Bellamy, UNICEF executive director, said. "Before AIDS, about 2% of all children in developing countries were orphans. By 1997, the figure had jumped to 7% in many African countries--in some countries the figures run as high as 11%."
The increasing number of AIDS orphans in sub-Saharan Africa means that there will also be increases in child labor and in the number of street children, Dr. Piot added.
Compared with children orphaned by other causes, AIDS orphans are at increased risk of malnutrition, illness, abuse and sexual exploitation, according to the report. These children are also frequently stigmatized, leaving them socially isolated and frequently deprived of education and other basic social services.
"The AIDS epidemic will not diminish until discrimination, including persistent gender bias and inequity, is eliminated," the report continued. "Throughout the world, but particularly in sub-Saharan Africa, the ratio of female to male AIDS cases is rising."
"Human, financial and organizational resources are needed on a massive scale if affected countries are to prevent this crisis from completely overwhelming health, education and other basic services," the report concludes.
The National Black Leadership Commission joined with UNAIDS and UNICEF to issue a "Call to Action," at the UN symposium yesterday. The organizations are urging "...governments to 'break the conspiracy of silence' surrounding the epidemic and instead to act with 'openness and urgency' to fight the discrimination and ostracism that too often accompany AIDS. (Reuters)
More than one fifth of injection drug users surveyed in Marseille, France, use vending machines as their primary source of syringes.
"By reaching a different--in particular, a younger--group of injection drug users, syringe vending machines can further the prevention of HIV and other blood-borne infections," Dr. Yolande Obadia, of Institut Paoli Calmettes, in Marseille, and multinational colleagues say in the December issue of the American Journal of Public Health: Journal of the American Public Health Association.
Vending machines, which accept used syringes and dispense sterile ones in return, were introduced in Marseilles in 1996. The team surveyed injection drug users who obtained syringes from vending machines, pharmacies and needle exchange programs. Of the 343 users identified, 21.3% reported using vending machines as their primary source of syringes.
These primary users of vending machines were more likely than other injection drug users to be younger than 30 years of age, to have never received drug maintenance treatment and to report not sharing needles or other drug injection paraphernalia, according to the report. These findings are of particular importance, the investigators say, since younger injection drug users are less likely to use needle exchange programs and pharmacies as a source of sterile needles.
The study "suggests that syringe vending machines can be a useful adjunct to existing needle exchange programs and pharmacy sales of sterile syringes without prescription," Dr. Obadia and colleagues say. "Whether the introduction of syringe vending machines would be appropriate in contexts such as the United States, where participation of high-risk young and short-term injection drug users in needle exchange programs is also uncommon, merits consideration." (Reuters)
World AIDS Day was marked in South Africa by scathing attacks on government's HIV/AIDS policies, cautious hope for a cure and colourful rallies where condoms were handed out like candy.
In Cape Town anti-AIDS activists accused President Thabo Mbeki of "passive genocide" through his refusal to supply the anti-AIDS drug AZT to pregnant women, in a ceremony in the city centre, attended by hundreds of delegates to the Parliament of the World's Religions.
Mbeki has said the drug is too expensive and that it has not been proven beyond doubt that AZT does in fact help prevent the transmission of the disease to unborn babies.
"We say to Mbeki that this decision is contrary to the principles of the constitution, is scientifically mistaken and is morally bankrupt," said US AIDS activist Cleve Jones, founder of the AIDS Memorial Quilt.
Jones, an AIDS sufferer who said drugs had kept him alive for the past 20 years, acknowledged that the South African government could not afford to provide the treatment.
But he said Mbeki should ask "the wealthy countries of the world and the big pharmaceutical companies" to help meet the costs of AZT.
South African anti-AIDS activist Adeline Mangcu, who said she was found to be HIV positive in 1994, accused the South African government of "passive genocide -- you just fold your arms and watch them die."
She said 160 babies are born every day in South Africa with the HIV virus and that it was now time for pharmaceutical companies, which had made "huge profits out of our people," to "give something back" by dropping the price of AZT.
In a speech prepared for World Aids Day, Mbeki, who is in Tanzania, avoided the drug row and urged South Africans to be responsible for their own health and change their behaviour to eradicate the disease.
"HIV/AIDS threatens to undermine our efforts to grow our economy and build a better life for all our people," he said.
"Every day, more people die as a result of AIDS in sub-Saharan Africa than anywhere else in the world."
According to the UN, four-fifths of the 2.5 million deaths from AIDS in 1998 were in sub-Saharan Africa.
Health Minister Manto Tshabalala-Msimang expressed the hope that a cure for AIDS would be found soon.
"We are taking positive steps to develop a vaccine. Let us build on the hope we have."
As acting president in Mbeki's absence, Home Affairs Minister Mangosuthu Buthelezi addressed a rally in Pretoria and pleaded with South Africans to relinquish local superstitions about AIDS.
"Let me state emphatically that AIDS cannot be cured. You cannot get better by engaging in sexual intercourse with a virgin. You cannot be cured by rape."
He also implored people not to discriminate against sufferers and not to spread the disease, saying: "There is nothing more repulsive or abominable than a person who intentionally spreads AIDS, out of revenge, selfishness or total disrespect."
Surveying the crowd who stomped to the sound of popular bands, handed around condoms and pinned them to their trousers, Buthelezi said: "There is one thing we can celebrate here today: the fact that we can beat AIDS."
In Cape Town, the national assembly speaker Frene Ginwala unveiled a giant red AIDS awareness ribbon draped across the building's entrance and said South Africa would begin allocating money in its national budget expressly for the fight against AIDS.
In KwaZulu-Natal province, believed to have the highest incidence of HIV in South Africa, AIDS awareness workers took their message straight to the people by boarding trains and handing condoms and pamphlets to commuters. (Agence France-Press)
The safety of the female condom needs to be evaluated before it can be recommended for use during anal sex, survey results suggest.
In six US cities, 2,277 gay and bisexual men who were not infected with the human immunodeficiency virus (HIV) -- the virus that causes AIDS -- answered a questionnaire about Reality, a female condom that has been approved by the US Food and Drug Administration for vaginal use. A total of 145 men said that they had used Reality for anal sex at least once in the previous 6 months.
About 40% of these men reported problems with the condom, including pain, difficulty inserting the device, and difficulty keeping it in place. Four users reported rectal bleeding.
"Men with any HIV-positive partners were 2 times more likely to have used female condoms than men whose partners were HIV-negative or of unknown HIV status," Dr. Michael Gross of Abt Associates in Cambridge, Massachusetts, and colleagues report in the November issue of the American Journal of Public Health.
Men who reported having receptive anal sex about once per month or more often were 3 times more likely than others to have used Reality.
In their report, Gross and his colleagues point out that men with HIV-infected partners and men who regularly have receptive anal sex are at higher risk of infection with the AIDS virus than other gay and bisexual men. Therefore, they say, reports of rectal bleeding associated with female condoms are of concern.
The researchers conclude that "use of the female condom for anal sex should be evaluated for safety and (effectiveness) before it is widely promoted." (Reuters)
The Philadelphia FIGHT Institutional Review Board is seeking additional members living with HIV. The Board, which meets monthly, reviews and monitors new HIV-related clinical reseach conducted at FIGHT. For more information, please contact Gary Seeley at 215-985-4448, ext. 231.